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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K171885
Device Name Radiance V4
Applicant
Gmv Soluciones Globales Internet S.A.U.
Calle De Isaac Newton, 11
Tres Cantos,  ES 28760
Applicant Contact Carlos Illana
Correspondent
Qserve Group, Us, Inc.
5600 Wisconsin Ave.
Chevy Chase,  MD  20815
Correspondent Contact Patsy Trisler JD, RAC
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received06/26/2017
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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